Emergent BioSolutions Initiates Phase 3 Clinical Study
Emergent BioSolutions Inc. recently announced the initiation of a Phase 3 trial to evaluate the lot consistency, immunogenicity, and safety of AV7909 (anthrax vaccine adsorbed with CPG 7909 adjuvant) following a two-dose schedule administered intramuscularly in healthy adults.
AV7909 is being developed for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure.
“Emergent is pleased with the advancement of the AV7909 development program,” said Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head at Emergent BioSolutions. “Dosing the first subject in this large clinical study is a milestone achievement and we look forward to continuing to execute on our development and procurement contract for AV7909.”
AV7909 is designed to elicit a faster immune response than the currently available anthrax vaccine. It is comprised of Anthrax Vaccine Adsorbed (AVA) in combination with an adjuvant, the immunostimulatory oligodeoxynucleotide compound CPG 7909. The addition of CPG 7909 to AVA has been shown, in previous Phase 1 and Phase 2 studies, to safely accelerate and enhance the immune response.
In evaluating the lot consistency of AV7909, the study will be using three consecutively manufactured lots of the vaccine candidate. This Phase 3 randomized, double-blind, parallel-group study plans to enroll 3,850 adults across 35 sites within the U.S. with an overall study duration of approximately 20 months. More information on the study is available on https://clinicaltrials.gov/ct2/show/NCT03877926